Multiplexed Multi-Electrode Neurostimulation Devices

ABSTRACT

Implantable stimulation devices are provided. Aspects of the devices include a multiplexed multi-electrode component configured for neural stimulation. The multiplexed multi-electrode component includes two or more individually addressable satellite electrode structures electrically coupled to a common conductor. The satellite structures include a hermetically sealed integrated circuit controller operatively coupled to one or more electrodes. Also provided are systems that include the devices of the invention, as well as methods of using the systems and devices in a variety of different applications.

RELATED APPLICATION AND CROSS REFERENCE

This application claims the benefit of U.S. Provisional Application Ser.No. 61/114,433 filed on Nov. 13, 2008, the entire disclosure of which isincorporated herein by reference.

FIELD OF THE INVENTION

The present invention is related to electrical devices and systems forstimulation of a target site and, more specifically, multiplexedrechargeable leads including multiple electrodes that are individuallyaddressable and include an inductive power source and power storageunits.

BACKGROUND

Implantable neurostimulators are used to deliver neurostimulationtherapy to patients to treat a variety of symptoms or conditions such aschronic pain, tremor, Parkinson's disease, epilepsy, incontinence, orgastroparesis. Implantable neurostimulators may deliver neurostimulationtherapy in the form of electrical pulses via implantable leads thatinclude electrodes. To treat the above-identified symptoms orconditions, implantable leads may be implanted along nerves, within theepidural or intrathecal space of the spinal column, and around thebrain, or other organs or tissue of a patient, depending on theparticular condition that is sought to be treated with the device.

With respect to implantable leads, several elements such as conductors,electrodes and insulators may be combined to produce a lead body. A leadmay include one or more conductors extending the length of the lead bodyfrom a distal end to a proximal end of the lead. The conductorselectrically connect one or more electrodes at the distal end to one ormore connectors at the proximal end of the lead. The electrodes aredesigned to form an electrical connection or stimulus point with tissueor organs. Lead connectors (sometimes referred to as terminals,contacts, or contact electrodes) are adapted to electrically andmechanically connect leads to implantable pulse generators or RFreceivers (stimulation sources), or other medical devices. An insulatingmaterial may form the lead body and surround the conductors forelectrical isolation between the conductors and for protection from theexternal contact and compatibility with a body.

Such leads may be implanted into a body at an insertion site and extendfrom the implant site to the stimulation site (area of placement of theelectrodes). The implant site may be a subcutaneous pocket that receivesand houses the pulse generator or receiver (providing a stimulationsource). The implant site may be positioned a distance away from thestimulation site, such as near the buttocks or other place in the torsoarea. One common configuration is to have the implant site and insertionsite located in the lower back area, with the leads extending throughthe epidural space in the spine to the stimulation site, such as middleback, upper back, neck or brain areas.

Current lead designs have different shapes, such as those commonly knownas paddle leads and percutaneous leads. Paddle leads, which aretypically larger than percutaneous leads, are directional and oftenutilized due to desired stimulus effect on the tissues or areas.However, current paddle leads require insertion using surgical means,and hence, removal through surgical means. Percutaneous leads aredesigned for easy introduction into the epidural space using a specialneedle. Therefore, such leads are typically smaller and more nearlycircular in cross-section than paddle-shaped leads. This reduced sizefacilitates their implantation in the body, allows their implantationinto more areas of the body, and minimizes the unwanted side effects oftheir implantation.

SUMMARY

Implantable neural stimulation devices are provided. Aspects of thedevices include a multiplexed multi-electrode component configured forneural stimulation. The multiplexed multi-electrode component includestwo or more individually addressable satellite electrode structureselectrically coupled to a common conductor. The satellite structuresinclude a hermetically sealed integrated circuit controller operativelycoupled to one or more electrodes. Also provided are systems thatinclude the devices of the invention, as well as methods of using thesystems and devices in a variety of different applications.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 provides a view of percutaneous lead according to an aspect ofthe invention, where the percutaneous lead includes several individuallyaddressable satellite electrode structures.

FIG. 1A provides an exploded view of an electrode structure of the leadof FIG. 1

FIG. 1B & FIG. 1C provide exploded views of the electrode structure ofFIG. 1 with four and six electrodes, respectively.

FIG. 2 provides a more detailed view of an individually addressablesatellite electrode structure as may be present in a lead according tothe invention.

FIGS. 3A to 3E provide views of a percutaneous neurostimulation systemand components thereof according to one aspect of the invention.

FIG. 4 provides a view of a multi-port connector that may be present ina system according to the invention.

FIG. 5 provides a view of a multi-bus connector that may be present in asystem according to the invention.

FIGS. 6A to 6C provide views of a percutaneous neurostimulation systemaccording to another aspect of the invention.

FIG. 7 provides a view of a branched percutaneous neurostimulationsystem according to the invention.

FIG. 8 provides a view of an individually addressable satelliteelectrode structure that includes a single electrode.

FIG. 9 provides a view of a paddle lead of the invention that includesthe individually addressable satellite electrode structure shown in FIG.8.

DETAILED DESCRIPTION

Implantable neural stimulation devices are provided. Aspects of thedevices include a multiplexed multi-electrode component configured forneural stimulation. The multiplexed multi-electrode component includestwo or more individually addressable satellite electrode structureselectrically coupled to a common conductor. The individually addressablesatellite electrode structures include a hermetically sealed integratedcircuit controller operatively coupled to one or more electrodes. Alsoprovided are systems that include the devices of the invention, as wellas methods of using the systems and devices in a variety of differentapplications.

In further describing various aspects of the invention, devices of theinvention are reviewed first in greater detail, followed by adescription of systems and methods of using the same in variousapplications, including neural stimulation applications.

FIG. 1 shows a lead 200 including multiplexed multi-electrode componentsthat are individually addressable satellite structures 202 positionedlongitudinally on the lead 200. The lead 200 includes two bus wires S1and S2, which are coupled to individually addressable electrodesatellite structures, such as individually addressable satelliteelectrode structure 202. FIG. 1A also shows individually addressablesatellite electrode structure 202 with an enlarged view. Individuallyaddressable satellite electrode structure 202 includes electrodes 212,214, 216, and 218, located in the four quadrants of the cylindricalouter walls of satellite 202. FIG. 1B provides a depiction of thearrangement of four electrodes. As indicated above, a given individuallyaddressable satellite electrode structure may include more or less thanfour electrode elements. For example, six electrode elements may bepresent, as shown in FIG. 1C. Each individually addressable satelliteelectrode structure also contains integrated circuit component insidethe structure which communicates with other satellite structures and/ordistinct control units, e.g., to receive neurostimulation signals and/orconfiguration signals that determine which of the different electrodesare to be coupled to bus wires S1 or S2 of FIG. 1A.

FIG. 2 shows a more detailed view of one type of individuallyaddressable segmented electrode structure 400. The configuration shownin FIGS. 1A, 1B and 2 may be viewed as a quadrant electrode. As shown inFIG. 2, flexible connections 401 are provided between a hermeticallysealed element 403 and elongated conductive members 405 and 407, similarto the conductive members S1 and S2 of FIG. 1. This design creates aflexible connection between the element 403 and the elongated conductivemembers 405 and 407. Additionally, the connections 401 each include asecuring element 404 to hold the element 403 in place. According to oneaspect of the invention, the element 403 is an integrated circuit andaccording to another aspect of the invention the element 403 is ahousing that contains multiple components, including a power storageunit and an integrated circuit. As shown, the elongated conductivemembers 405 and 407 are placed into an inner lumen 402 of the flexibleconnections 401. The element 403 will be referenced hereinafter asintegrated circuit 403 according to one aspect of the invention and forillustrative purposes. The integrated circuit 403 is attached to fourdistinct electrodes 409A, 409B, 409C and 409D by junctures 411 and 417,which are also present on the opposite side of the structure 400, butnot shown. The electrodes 409A, 409B, 409C and 409D are joined togetherin a suitable configuration structure 413, which may be made of anyconvenient material, such as polyetheretherketone (PEEK). A guide wirelumen 415 runs beneath integrated circuit 403 and beneath and/or betweenelongated conductive members 405 and 407, all running through orcontained with the area defined by the electrodes 409A, 409B, 409C and409D.

Additional details regarding individually addressable satelliteelectrode structures can be found in PCT application serial no.PCT/US2005/031559 published as WO 2006/029090; PCT application serialno. PCT/US2005/046815 published as WO 2006/069323; PCT applicationserial no. PCT/US2005/046811 published as WO 2006/069322; and U.S.application Ser. No. 11/939,524 published as US 2008-0114230 A1; thedisclosures of which are herein incorporated by reference.

As summarized above, implantable neural stimulation devices areprovided. The implantable neural stimulation devices are configured forneural stimulation. As such, they are structured specifically for neuralstimulation applications, in terms of device form factor or shape, aswell as control unit programming. Devices of the invention may have avariety of shapes that are suitable for use in neural stimulationapplications, including shapes found in traditional percutaneous leads,paddle leads as well as other neurostimulation specific configurations.Programming (a set of instructions that are implemented by a processorto perform a given task) that is specific for neural stimulationprotocols may also be included in components of devices of theinvention, such as integrated circuit elements of the individuallyaddressable satellite electrode structures of the devices. Programmingthat may be part of the devices may include a full set of instructionsfor a given task or a partial set of instructions that is employed inconjunction with other instructions associated with components distinctfrom the devices, where such additional instructions may be present in adistinct implantable control unit to which the device may be operativelycoupled during use.

As the devices of the invention are implantable, they are configured tomaintain functionality when present in a physiological environment,including a high salt, high humidity environment found inside of a body.Implantable devices of the invention are configured to maintainfunctionality under these conditions for two or more days, such as oneweek or longer, four weeks or longer, six months or longer, one year orlonger, including five years or longer. In some instances, theimplantable devices are configured to maintain functionality whenimplanted at a physiological site for a period ranging from one toeighty years or longer, such as from five to seventy years or longer,and including for a period ranging from ten to fifty years or longer.

Devices of invention include a multiplexed multi-electrode component.Multiplexed multi-electrode components include two or more electrodeswhich are electrically coupled, either directly or through anintermediate connector, to a common conductor or set of commonconductors, such that the two or more electrodes share one or moreconductors. The term “conductor” refers to a variety of configurationsof electrically conductive elements, including wires, cables, etc. Avariety of different structures may be implemented to provide themultiplex configuration. Multiplex configurations of interest include,but are not limited to, those described in: PCT application no.PCT/US2003/039524 published as WO 2004/052182; PCT application no.PCT/US2005/031559 published as WO 2006/029090; PCT application no.PCT/US2005/046811 published as WO 2006/069322; PCT application no.PCT/US2005/046815 published as WO 2006/069323; and PCT application no.PCT US2006/048944 published as WO 2007/075974; the disclosures of whichare herein incorporated by reference.

The multiplexed multi-electrode components include two or moreindividually addressable satellite electrode structures. In someinstances, more than two individually addressable satellite structuresare present in the device, such as three or more, four or more, five ormore, six or more, ten or more, twenty or more (including twenty-four),thirty or more, fifty or more, etc. Individually addressable satelliteelectrode structures are those that can be individually controlled froma site remote from the satellite electrode structure, such as a separateimplanted control unit to which the device is operatively coupled or toan extracorporeal control unit.

Satellite electrode structures are structures that include an integratedcircuit control device and at least one electrode element. The satelliteelectrode structures of the invention include control circuitry in theform of an integrated circuit that imparts addressability to thesatellite electrode structure. Integrated circuit components of thestructures are constructs that include circuitry components and a solidsupport. The solid support may be small, for example where it isdimensioned to have a width ranging from 0.01 mm to 100 mm, such as from0.1 mm to 20 mm, and including from 0.5 mm to 2 mm; a length rangingfrom 0.01 mm to 100 mm, such as from 0.1 mm to 20 mm, and including from0.5 mm to 2 mm, and a height ranging from 0.01 mm to 10 mm, includingfrom 0.05 mm to 2 mm, and including from 0.1 mm to 0.5 mm. The solidsupport element may take a variety of different configurations, such asbut not limited to: a chip configuration, a cylinder configuration, aspherical configuration, a disc configuration, etc. A particularconfiguration may be selected based on intended application, method ofmanufacture, etc. While the material from which the solid support isfabricated may vary considerably depending on the particular device forwhich the device is configured for use, in certain instances the solidsupport is made up of a semiconductor material, such as silicon.

Integrated circuit components of the individually addressable satelliteelectrode structures may include a number of distinct functional blocks,i.e., modules. In some instances, the circuits include at least thefollowing functional blocks: a power extraction functional block; anenergy storage functional block; a sensor functional block; acommunication functional block; and a device configuration functionalblock, etc.

Within a given satellite electrode structure, at least some of, e.g.,two or more, up to and including all of, the functional blocks may bepresent in a single integrated circuit. By single integrated circuit ismeant a single circuit structure that includes all of the differentdesired functional blocks for the device. In these types of structures,the integrated circuit is a monolithic integrated circuit that is aminiaturized electronic circuit which may be made up of semiconductorand passive components that have been manufactured in the surface of athin substrate of semiconductor material. Sensors of the invention mayalso include integrated circuits that are hybrid integrated circuits,which are miniaturized electronic circuits constructed of individualsemiconductor devices, as well as passive components, bonded to asubstrate or circuit board.

A given satellite electrode structure may include a single electrodeelement coupled to an integrated circuit, or two or more electrodescoupled to the same integrated circuit, such as three or moreelectrodes, four or more electrodes, six or more electrodes, etc. Invarious aspects, the structure includes two or more electrode elements,such as three or more electrode elements, including four or moreelectrode elements, e.g., where the structure is a segmented electrodestructure. The various electrode elements may be positioned inthree-dimensional space relative to their controlling integrated circuitto which they are electronically coupled in a number of different ways.For example, the multiple electrode elements may be radiallydistributed, i.e., axially uniformly positioned, about an integratedcircuit. Alternatively, the multiple electrode elements may bepositioned to one side of an integrated circuit.

Individually addressable satellite electrode structures of the deviceshave hermetically sealed integrated circuit components, such that theyinclude a sealing element which seals the integrated circuit from theimplanted environment so that the structure maintains functionality, atleast for the intended lifespan of the device. The nature of the sealingelement may vary, so long as it maintains the functionality of thesatellite structure in the implanted environment for the desired periodof time, such as one week or longer, one month or longer, one year orlonger, five years or longer, ten years or longer, twenty-five years orlonger, forty years or longer.

In some instances, the sealing element is a conformal, void-free sealinglayer, where the sealing layer is present on at least a portion of theouter surface of the integrated circuit component (described above). Insome instances, this conformal, void-free sealing layer may be presenton substantially all of the outer surfaces of the integrated circuitcomponent. Alternatively, this conformal, void-free sealing layer may bepresent on only some of the surfaces of the integrated circuit, such ason only one surface or even just a portion of one surface of theintegrated circuit component. As such, some sensors have an integratedcircuit component completely encased in a conformal, void free sealinglayer. Other sensors are configured such that only the top surface of anintegrated circuit component is covered with the conformal, void-freesealing layer.

The conformal, void-free sealing layer may be a “thin-film” coating, inthat its thickness is such that it does not substantially increase thetotal volume of the integrated circuit structure with which it isassociated, where any increase in volume of the structure that can beattributed to the layer may be 10% or less, such as 5% or less,including 1% or less by volume. In some instances, the seal layer has athickness in a range from 0.1 to 10.0 μm, such as in a range from 0.3 to3.0 μm thick, and including in a range 1.0 μm thick.

The seal layer may be produced on the integrated circuit component usingany of a number of different protocols, including but not limited toplanar processing protocols, such as plasma-enhanced-chemical-vapordeposition, physical-vapor deposition, sputtering, evaporation,cathodic-arc deposition, low-pressure chemical-vapor deposition, etc.

Additional description of conformal, void-free sealing layers that maybe employed for sensors of the invention is provided in PCT applicationserial no. PCT/US2007/009270 published under publication no.WO/2007/120884, the disclosure of which is herein incorporated byreference.

Also of interest as sealing elements are corrosion-resistant holdershaving at least one conductive feed-through and a sealing layer; wherethe sealing layer and holder are configured to define a hermeticallysealed container that encloses the integrated circuit component. Theconductive feed-through may be a metal, such as platinum, iridium etc.,an alloy of metal and a semiconductor, a nitride, a semiconductor orsome other convenient material. In some instances, thecorrosion-resistant holder comprises silicon or a ceramic. Whiledimensions may vary, the corrosion-resistant holder may have walls thatare at least 1 μm thick, such as at least 50 μm thick, where the wallsmay range from 1 to 125 μm, including from 25 to 100 μm. The sealinglayer may be metallic, where metals of interest include noble metals andalloys thereof, such as platinum and platinum alloys. Dimensions of thesealing layer may also vary, ranging in some instances from 0.5 μm thickor thicker, such as 2.0 μm thick or thicker, and including 20 μm thickor thickness, where sealing layer thicknesses may range from 0.5 to 100μm, such as from 1 to 50 μm. In certain configurations, the structurefurther includes an insulative material present in the hermeticallysealed volume. In some cases, the hermetically sealed volume ranges from1 pl. to 1 ml.

In some instances, the in-vivo corrosion-resistant holder is a structureconfigured to hold an integrated circuit component such that theintegrated circuit component is bounded on all but one side by the wallsof the holder. For example, the holder may include side walls and abottom, where the holder may have a variety of different configurationsas long as it contains the integrated circuit component in a manner suchthat the component is held in a volume bounded on all but one side.Accordingly, the shape of the holder may be square, circular, ovoid,rectangular, or some other shape as desired.

Additional description of corrosion resistant holders that may beemployed for sensors of the invention is provided in PCT applicationserial no. PCT/US2005/046815 published under publication no.WO/2006/069323, the disclosure of which is herein incorporated byreference.

As indicated above, multiplexed multi-electrode components of theinvention may include a single multiplexed lead element along which thetwo or more, such as ten or more, twenty or more, or even twenty four ormore individually addressable satellite electrode structures arelongitudinally or otherwise positioned along the multiplexed lead. Bysingle multiplexed lead element is meant that the multiplex componentand two or more individually addressable satellite structures areintegrated into the same physical lead structure, such that themultiplexed multi-electrode component is not made up of two or moredistinct, readily separable components that are coupled together.

Another example of a multiplexed multi-electrode component that is madeup of a single multiplexed lead element is shown in FIG. 3A. In FIG. 3A,device 300 includes a multiplexed lead 310 which is configured forneural stimulation by being structured to be placed along the spine inthe epidural space. The lead 310 extends along a substantial length ofthe spine, for example, fifty percent or more, such as seventy-fivepercent or more, including eighty percent or more of the length of thespine. Distributed longitudinally along the length of the lead 310 areindividually addressable satellite electrode structures 320. The lead310 is operatively coupled to a control unit 330 via a suitableconnection, such as an IS-1 connection.

FIG. 3B, a cross-section of vertebral body 340 is shown with spinal cord345 and spinal nerve 350. Also shown is a portion of the device 300 incross section. The device 300 is configured for neural stimulation asthe cross-section of device 300 is shaped to conform to the surface ofspinal cord 345. FIG. 3C provides a more detailed view of thecross-section of device 300. As shown in FIG. 3C, an individuallyaddressable satellite structure 320 is shown having hermetically sealedintegrated circuit component 325 coupled to common conductors 327 and329 as well as four electrodes 360.

Referring now to FIG. 3C, the electrodes 360 are positioned to one sideof integrated circuit 325 of the device 300. Where desired, theelectrodes 360 are part of a given individually addressable satelliteelectrode structure 320 and may have a staggered configured, such as theconfiguration shown in FIG. 3D.

Referring now to FIG. 3D, electrodes 372, 374, 376 and 378 arepositioned along one side of device 300 in a staggered configuration.

Referring now to FIG. 3E, both sides of the device 300 are shown forclarity. This configuration includes four electrodes 382, 384, 386, and388 positioned radially on device 300, and in fact uniformly axiallypositioned about the lead element of the device 300.

In alternative configurations to those described above, multiplexedmulti-electrode lead components of the devices may also be made up oftwo or more distinct sub-components that are operatively coupled to eachother to produce the multiplexed multi-electrode lead component. Forexample, multiplexed multi-electrode lead components of the inventionmay include a first subcomponent that is made up of a multiplexed lead(such as a lead having three or fewer, such as two or fewer conductiveelements) and a second subcomponent that includes two or moreindividually addressable satellite electrode structures.

Referring now to FIG. 4, an implantable controller 420 is shownconnected to a multiplexed multi-electrode component 430 through amultiplexed lead 440. The controller 420 is connected to the multiplexedlead 440 via an IS-1 connection 422. The multiplexed lead 440 iselectrically coupled to a multi-port connector 450, wherein themulti-port connector 450 includes five distinct individually addressablesatellite integrated circuits 452, 454, 455, 456, and 457, where anindividually addressable satellite structure is provided for eachelectrode lead port 453. Also shown is an electrode lead 460 connectedto the multi-port connector 450 via connectors 458 and 461. The lead 460includes four electrodes 462, 463, 464, and 465 which are individuallycontrollable by integrated circuit 452. Connectors 441 and 451 areemployed to connect the lead 440 with multi-port connector 450. Thelength of lead 440 may vary greatly depending on the particularimplanted configuration, where in some instances lead 440 may be 10 mmor longer, such as 25 mm or longer, including 50 mm or longer, as wellas 100 mm or longer.

Another example of a multiplexed multi-electrode component that is madeup of two or more subcomponents is shown in FIG. 5. The multiplexedmulti-electrode component 500 includes a securing point 510, a controlunit 520 and a multi-bus connector 530. The multi-bus connector 530 iselectrically coupled to multiplexed lead elements 540, 550 or 560 alongwhich the two or more individually addressable satellite electrodestructures (not shown) are longitudinally positioned. The control unit520 is operatively connected to the multiplexed multi-electrodecomponent 500, such as through an IS-1 connector.

Devices of the invention may have a variety of configurations, includinglinear and branched. An example of a linear configuration is shown inFIG. 3A. An example of a branched configuration is shown in FIG. 7. InFIG. 7, device 700 includes a core multiplexed multi-electrode lead 710with multiple branch leads 722, 723, 724, 725, 726, 727, and 728 in aconfiguration analogous to the naturally occurring nervous system havingspinal cord and multiple spinal nerves which branch off the spinal cord.The core lead 710 and each branch have a multiplex configuration inwhich two wires run the length of the lead and multiple individuallyaddressable satellite electrode structures are longitudinally positionedalong the lead and coupled to the two wires in the core lead 710.Because of this multiplex configuration, each lead has a small outerdiameter or low-profile. Where desired, each electrode may be employedto sense as well as stimulate. In this manner, breaks in the naturalnervous system 740 can be bridged by sensing the nerve signal on oneside of the break and then stimulating with the same signal on the otherside of the break. The branched structure shown in FIG. 7 may beemployed to replace a portion of a patient's nervous system or theentire nervous system, as desired.

As described above, multiplexed multi-electrode components of thedevices may include one or more lead components. Lead components areelongated structures having lengths that are 2 times or longer thantheir widths, such as 5 times or longer than their widths, including 10,15, 20, 25, 50, 100 times or longer than their widths. In certaininstances, the leads have lengths of 10 mm or longer, such as 25 mm orlonger, including 50 mm or longer, such as 100 mm or longer. A varietyof different lead configurations may be employed, where the lead invarious aspects is an elongated cylindrical structure having a proximaland distal end. The proximal end may include a connector element, e.g.,an IS-1 connector, for connecting to a control unit, e.g., present in a“can” or analogous device. The lead may include one or more lumens,e.g., for use with a guidewire, for housing one or more conductiveelements, e.g., wires, etc. The distal end may include a variety ofdifferent features as desired, e.g., a securing means, etc. Leads may befabricated as flexible structures, where internal conductor elements mayinclude wires, coils or cables made of a suitable material, such asalloy MP35N (a nickel-cobalt-chromium-molybdenum alloy), platinum,platinum-10 iridium, etc. The lead body may be any suitable material,such as a polymeric material, including polyurethane or silicone.

Lead components of the invention may have a variety of shapes, asdesired. In some instances, the leads have a standard percutaneousshape, as found in conventional percutaneous neural stimulation leads.In some instances, the leads have a standard paddle shape, as found inconventional paddle neural stimulation leads.

Any of a variety of different protocols may be employed in manufacturingthe devices of the invention. For example, molding, deposition andmaterial removal, planar processing techniques, such asMicro-Electro-Mechanical Systems (MEMS) fabrication, may be employed.Deposition techniques that may be employed in certain aspects offabrication of the devices or components thereof include, but are notlimited to: electroplating, cathodic arc deposition, plasma spray,sputtering, e-beam evaporation, physical vapor deposition, chemicalvapor deposition, plasma enhanced chemical vapor deposition, etc.Material removal techniques of interest include, but are not limited to:reactive ion etching, anisotropic chemical etching, isotropic chemicaletching, planarization, e.g., via chemical mechanical polishing, laserablation, electronic discharge machining (EDM), etc. Also of interestare lithographic protocols. Of interest in certain aspects is the use ofplanar processing protocols, in which structures are built up and/orremoved from a surface or surfaces of an initially planar substrateusing a variety of different material removal and deposition protocolsapplied to the substrate in a sequential manner.

In some instances, laser cut wires are employed as conductive elementsfor devices of the invention, such as for conductive elements of leadelements of devices of the invention. For example, conductive elementsmay be laser cut from a single sheet of metal. The pattern of the lasercut conductive elements may be chosen to match the positioning of theindividually addressable satellite electrode structures of the lead. Inthis manner, the conductors and electrode structures may be aligned andthen overlaid with the appropriate polymeric material to produce thedesired lead structure. The laser cut conductive elements may have avariety of configurations from linear to curvilinear, sinusoidal orother fatigue resistance configuration. Instead of laser cutting, theconductor could also be fabricated using a deposition protocol, such asdescribed above.

Devices of the invention may be implanted using any convenient protocol.Standard implantation procedures for percutaneous and paddle leads maybe adapted for implantation of devices of the invention. The devices maybe configured for ease of implantation. For example, devices may includea deployable element, such as lead components that inflate, e.g., with agas or suitable liquid medium, to assume a desired configuration.

Also provided are systems that include one more neural stimulationdevices as described above operatively coupled to an implantablecontroller, which may be an implantable pulse generator. The implantablecontroller may be any suitable controller, including any of a number ofimplantable pulse generators currently employed for neurostimulationprocedures, where the devices may be modified as desired to work withmultiplexed multi-electrode neurostimulation devices of the invention.Also part of the systems may be any number of additional components, asdesired, including extra-corporeal control units configured to transmitdata and/or power to and/or receive data from the implantablecomponents.

Also provided are methods of using the systems of the invention. Themethods of the invention generally include: providing a system of theinvention, e.g., as described above, that includes an implantablecontroller and neurostimulation device. The system may be implanted in asuitable subject using any convenient approach. Following implantation,the system may be employed to as desired to treat a condition ofinterest.

FIGS. 6A to 6B show examples of systems and methods for their use. InFIG. 6A system 600 includes two multiplexed multi-electrode leads 610and 620 initially positioned such that they emerge from the body at port630. Leads 610 and 620 are coupled to an external control unit 640 whichprovides power and also allows modification of programming. As shown inFIG. 6B, once the system 600 has been implanted and initiallyprogrammed, the external control unit 640 of FIG. 6A is replaced byinternal control unit 650, which is connected to leads 610 and 620 byconnector 660. FIG. 6C shows a variation of the system in FIG. 6B, whereleads 610 and 620 are connected to remotely implanted control unit 670via connector 660 and extender 680.

During use, a health care professional, such as a physician or otherclinician, may select values for a number of programmable parameters inorder to define the neurostimulation therapy to be delivered to apatient. For example, the health care professional may select a voltageor current amplitude and pulse width for a stimulation waveform to bedelivered to the patient, as well as a rate at which the pulses are tobe delivered to the patient and a duty cycle. The health careprofessional may also select as parameters particular electrodes withinthe electrode set carried by the leads to be used to deliver the pulses,and the polarities of the selected electrodes. A group of parametervalues may be referred to as a program in the sense that they drive theneurostimulation therapy to be delivered to the patient.

A health care professional may select parameter values for a number ofprograms to be tested on a patient during a programming session, forexample as provided in FIG. 6A, using a programming device. Theprogramming device directs the implantable neurostimulator implanted inthe patent to deliver neurostimulation according to each program, andthe health care professional collects feedback from the patient, e.g.,rating information, for each program tested on the patient. The healthcare professional then selects one or more programs for long-term use bythe implantable neurostimulator based on the rating information.

Implantable neurostimulators device of the invention may be employed ina variety of different applications. Examples of applications includethe use of the devices and systems to deliver neurostimulation therapyto patients to treat a variety of symptoms or conditions such as chronicpain, tremor, Parkinson's disease, epilepsy, incontinence, orgastroparesis. Typically, implantable neurostimulators deliverneurostimulation therapy in the form of electrical pulses via leads thatinclude electrodes. To treat the above-identified symptoms orconditions, for example, the electrodes may be located proximate to thespinal cord, pelvic nerves, or stomach, or within the brain of apatient.

FIG. 8 provides a cross-section view of a laser cut conductive element800 of an individually addressable satellite electrode structure 810.Integrated circuit component 820 is in electrical contact with laser cutconductive element 800. Conformal void free layer 830 is present on topof integrated circuit 820 and, upon overlay of the polymeric coating,hermetically seals the integrated circuit 820. Deposited singleelectrode 850 is present on top of layer 830 and connected to circuit820 via connector 840. Electrode 850 may be deposited using anyconvenient protocol, such as cathodic arc deposition.

FIG. 9 shows a paddle lead 900 that includes multiple individuallyaddressable satellite electrode structures 810. Underlying the shownelectrode structures 810 may be a laser cut pattern of conductiveelements as described above. As shown, all of the electrode structures810 of the paddle 900 are coupled to two wires 910 and 920 such that thepaddle 900 has a multiplexed configuration.

Also provided are kits that include the devices or components therefore,e.g., lead elements, connector elements, controllers, etc. In variousaspects of the subject kits, the kits will further include instructionsfor using the subject devices or elements for obtaining the same (e.g.,a website URL directing the user to a webpage which provides theinstructions), where these instructions are typically printed on asubstrate, which substrate may be one or more of: a package insert, thepackaging, reagent containers and the like. In the subject kits, the oneor more components are present in the same or different containers, asmay be convenient or desirable.

It is to be understood that this invention is not limited to particularaspects described, as such may vary. It is also to be understood thatthe terminology used herein is for the purpose of describing particularaspects only, and is not intended to be limiting, since the scope of thepresent invention will be limited only by the appended claims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the invention. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges and are also encompassed within the invention, subject toany specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present invention, representativeillustrative methods and materials are now described.

All publications and patents cited in this specification are hereinincorporated by reference as if each individual publication or patentwere specifically and individually indicated to be incorporated byreference and are incorporated herein by reference to disclose anddescribe the methods and/or materials in connection with which thepublications are cited. The citation of any publication is for itsdisclosure prior to the filing date and should not be construed as anadmission that the present invention is not entitled to antedate suchpublication by virtue of prior invention. Further, the dates ofpublication provided may be different from the actual publication dateswhich may need to be independently confirmed.

It is noted that, as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. It is further noted that the claimsmay be drafted to exclude any optional element. As such, this statementis intended to serve as antecedent basis for use of such exclusiveterminology as “solely,” “only” and the like in connection with therecitation of claim elements, or use of a “negative” limitation.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual aspects described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalaspects without departing from the scope or spirit of the presentinvention. Any recited method can be carried out in the order of eventsrecited or in any other order which is logically possible.

1. An implantable device for target site stimulation, the devicecomprising: a multiplexed lead comprising at least one conductor; aplurality of multiplexed addressable units secured at predeterminedlocations along the conductor, wherein each addressable unit comprises:a multi-port connector defining a plurality of ports, wherein each portreceives an electrode lead that is electrically coupled to and securedto the multi-port connector and each electrode lead includes a pluralityof independently excitable electrodes; and a plurality of independentlyaddressable integrated circuits corresponding to the number of definedports in the multi-port connector, wherein each circuit is electricallycoupled to the corresponding electrode lead at the corresponding portand wherein each circuit controls the power flowing to each of theplurality of independently excitable electrodes of the respectiveelectrode lead in the corresponding port; and a hermetically sealedcontrol unit electrically coupled to one end of the conductor distalfrom the addressable units, wherein the control unit provides controlinformation and power to each of the plurality of multiplexedaddressable units through the conductor.
 2. The implantable device ofclaim 1 wherein the multiplexed addressable units are arranged andmultiplexed in a linear configuration.
 3. The implantable device ofclaim 1 wherein the multiplexed addressable units are arranged andmultiplexed in a branched configuration.
 4. The implantable device ofclaim 1 wherein at least one electrode lead comprises four independentlyexcitable electrodes.
 5. The implantable device of claim 4 wherein thefour independently excitable electrodes are uniformly and axiallypositioned about the respective electrode lead.
 6. The implantabledevice of claim 5 wherein at least one other electrode lead comprisessix independently excitable electrodes.
 7. The implantable device ofclaim 6 wherein the six independently excitable electrodes are uniformlyand axially positioned about the respective electrode lead.
 8. Theimplantable device of claim 1 wherein the multiplexed lead furthercomprises a second conductor electrically coupled to the control unit atone end and electrically coupled to the addressable units along at leasta portion of its length.
 9. The implantable device of claim 1 whereinthe plurality of independently excitable electrodes of at least oneelectrode are positioned radially about the respective electrode lead.10. The implantable device of claim 1 wherein the target site is aspinal nerve and wherein the device is shaped to at least partiallysurround the spinal nerve and wherein the multiplexed lead furthercomprises a second conductor secured and electrically coupled to atleast a portion of the plurality of addressable units.
 11. Theimplantable device of claim 10 wherein the plurality of independentlyexcitable electrodes of at least one electrode lead are positioned onone side of the respective electrode lead.
 12. The implantable device ofclaim 11 wherein the plurality of independently excitable electrodes ofat least one other electrode lead are staggered along the respectiveelectrode lead.
 13. The implantable device of claim 1 furthercomprising: a target lead electrically coupled to the control unit,wherein the target lead comprises: a conducting wire continuing along atleast a portion of the length of the target lead; a hermetically sealedaddressable target controller electrically coupled to the conductingwire and positioned at one end of the target lead; a plurality ofaddressable target units including a plurality of electrodes whereineach target unit is electrically coupled to the conducting wire throughthe target controller, wherein the control unit transmits programminginformation to the target controller of the target lead.
 14. The systemof claim 12 wherein the system further comprises a power storage unitcoupled to the conductor of the lead for supplying power to theelectrode structures through the integrated circuit controller.
 15. Thesystem of claim 12 wherein the plurality of independently addressableintegrated circuits are hermetically sealed.